Active clinical trials for "Renal Insufficiency, Chronic"

Chronic kidney disease (CKD) is a common disease affecting 10-12% of the adult population and characterize with high-risk cardiovascular morbidity and mortality with progression of CKD. Treatment with sodium-glucose cotransporter 2 inhibitors (iSGLT2) not only improves hyperglycemia and type 2 diabetes (T2D) but also results in body-weight loss, a reduction in blood pressure, and a decrease of cardiovascular events and progression of renal failure in both diabetes and non-diabetes patients.(Heerspink et al. 2020) Therefore, dapagliflozin is now associated with the inhibitors of the renin-angiotensin system to reduce kidney events. However, the mechanisms underlying the effects of dapagliflozin on the renal function remain unclear. When renal failure occurs, it impairs the removal of several metabolites called uremic retention solutes. If these retention solutes exhibit deleterious interferences with biochemical/physiological functions, they are referred to as uremic toxins as they can contribute to the manifestations of the uremic syndrome and are associated with a high cardiovascular morbidity and mortality and with progression of CKD. Many of the uremic toxins are not produced by the body itself but rather derived from gut microbiota metabolism such as the well-known trimethylamine-N-oxide (TMAO),p-cresyl sulfate (PCS), phenyl sulfate (PS), indoxyl sulfate (IS), and indole-3-acetic acid (IAA).The gut microbiota composition in a uremic context has been the subject of an increasing number of publications and majority of them confirm a decrease of gut microbiota richness and deep modifications.Recently, an animal study suggested that dapagliflozin, subtly improve the composition of the gut microbiota in mice with T2D and another preliminary clinical study didn't observe a modification in the fecal microbiome after dapagliflozin initiation.But in other study, empagliflozin significantly reshaped the gut microbiota after 1 month of treatment in T2D patients and be associated with shifts in plasma metabolites. Similarly, canagliflozin reduces plasma uremic toxins in a CKD mice model.However, it remains unknown whether treatment with dapagliflozin alters the gut microbiota in CKD patients without T2D; furthermore, the relationship between the gut microbiota, uremic toxins production and CKD-related beneficial effects of dapagliflozin remains elusive. Herein, the investigator will investigate the clinical benefits of dapagliflozin and possible associations between its renal function benefits and alterations in plasmatic gut microbiota-derived metabolites and the gut microbiota composition in non-T2D CKD patients. To this end, the investigator will conduct an observational clinical trial in non-T2D CKD patients with the primary aim of investigating dapagliflozin-induced compositional changes of intestinal gut microbiota.

This is a single-center, double blind, randomized, parallel-arms study designed to investigate the effects of a six-month treatment with the SGLT2i dapagliflozin on markers of kidney senescence, inflammation and tubulointerstitial damage compared to placebo. These mechanisms of renal damage will be investigated in proximal tubular epithelial cells (PTECs) isolated from urine from patients with CKD with or without T2DM and in renal biopsy specimens in a subgroup of patients with diabetic kidney disease.

The protective nitric oxide (NO) effects are mediated by selective pulmonary vasodilation and improvement of arterial oxygenation in hypoxemic patients by reducing intrapulmonary shunting and improving ventilation-perfusion coordination. Inhaled NO has been used for years to treat acute respiratory failure and pulmonary hypertension in anesthesia and intensive care. The nephroprotective role of NO was studied in an experimental model of contrast-induced nephropathy. The primary aim of this prospective, double-blind, randomized, parallel-group, controlled trial is to test the hypothesis that perioperative conditioning of patients with NO at a dose of 80 ppm, obtained by plasma-chemical synthesis technology, through a ventilator and an extracorporeal circulation circuit reduces the incidence of acute kidney injury (AKI) in patients with an initially high risk of kidney damage due to the presence of preoperative chronic kidney disease (CKD). The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk NRMC for elective surgery with high risk of AKI in the perioperative period

Justification: Studies in recent years have shown that suffering an episode of acute kidney injury (AKI) is an independent risk factor for developing chronic kidney disease (CKD), which is associated with cardiovascular complications, increases medical care costs, and decreases survival. These AKI to ERC transition cases add to the growing number of CKD cases already being seen globally. It is for them that in recent years therapeutic strategies have been sought to reduce or stop this process of transition from AKI to CKD. Objective: To evaluate the efficacy and safety of the use of dapagliflozin plus standard medical treatment (TMS), compared with only TMS for 21 days, in hospitalized patients with a diagnosis of severe AKI (KDIGO 3) in reducing the incidence of CKD to 18 months of follow-up. Design: Randomized, single center, open study. 100 hospitalized patients with a diagnosis of AKI KDIGO 3, without previous CKD, will be randomized to receive 10 mg of dapagliflozin every 24 h for 21 days + TMS or only TMS. During their follow-up, baseline blood and urine samples will be taken and at 3, 6, 12 and 18 months. At 18 months, the development of CKD will be assessed using the KDIGO clinical criteria and with the determination of urinary biomarkers (Serpina A3, HSP72, KIM 1 and NGAL).

Polysaccharide super paramagnetic ferric oxide injection is an iron supplement developed for patients with iron deficiency anemia. Due to its characteristics, it has the potential to be a contrast agent. The DJTCSCYHT-I-04 study is a single-center, multiple-strength and single-dose phase I clinical study on cardiovascular MRI in patients with chronic kidney disease, aiming to investigate the effects and safety of multi-strength, single-dose at different time points, and to provide reference for clinical diagnosis and MRI enhancement.

Polycystic Kidney Disease (PKD) is the most common genetic disease leading to End Stage Kidney Disease (ESKD), affecting between 1 in 500-1000 individuals from every ethnic group. The autosomal dominant (ADPKD) form arises from a two-hit downregulation of proteins encoded by either PKD1 or PKD2. Although many potential therapies have been studied to slow progression of ADPKD, none to date have been proven to be both safe and effective in slowing disease progression. Cholesterol-lowering agents called statins have shown promise in the treatment of younger ADPKD patients, reducing inflammation and progression as assessed by kidney growth, but their utility appears to be limited in older populations and those with more advanced chronic kidney disease (CKD). Recent evidence suggests that acidosis, as often seen in patients with worsening CKD and which may enhance CKD progression, limits the effectiveness of statins and enhances their potential toxicity. The investigators thus hypothesize that correction of acidosis along with statin treatment will be a safe and effective therapeutic regimen to slow CKD progression in the adult ADPKD population and improve overall quality of life in these patients. To test this hypothesis, the investigators will conduct a pilot open-label randomized clinical trial in ADPKD patients with estimated GFR >45 min (Stage 1-3a CKD) comparing three treatment groups: control, atorvastatin (20 mg po qd), and atorvastatin plus sodium bicarbonate tablets (upto 1800mg po total daily dose) over one year. At the beginning of the study, the investigators will determine the genotype of the trial participants. During the study period, through study visits along with serial blood draws and urinary measurements, the investigators will evaluate safety and tolerability of these treatment regimens, follow renal function and investigate the role of these treatments on acidosis, inflammatory and metabolic biomarkers in patients enrolled at an outpatient facility. Serial follow-up imaging study will also be done in selected patients. This study will establish the framework for larger clinical trials in ADPKD. Moreover, if the results of this study suggest safety/tolerability or potential benefits of statins and alkali therapy in this ADPKD population, the investigators will seek extramural funding for a larger clinical trial to test this therapeutic strategy in ADPKD.

The indication of Pu Yang Wan Wu Tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness. Pu Yang Wan Wu Tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. Huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. Huangqi and Danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria. This research will use the compound Chinese medicine, Pu Yang Wan Wu Tang. Those treatments combined Western medicine to assess the efficacy and drug safety on the CKD cases. Series of blood and urine were collected regularly during study to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety. The final goal of the plan is to establish the new indication of Pu Yang Wan Wu Tang and enhance the interaction and cooperation between Chinese and Western medicine.

The use of contrast media (CM) poses a risk of post-contrast acute kidney injury (PC-AKI), especially among patients chronic kidney disease (CKD). International guidelines recommend intravenous (IV) hydration with isotonic 0.9% NaCl for three-four hours pre-contrast and four-six hours post-contrast. Recent studies have proven that oral hydration or no hydration is non-inferior to IV hydration in patients with mild to moderate CKD (eGFR 30-60 mL/min/1.73 m2). However, no randomized controlled trials have evaluated alternative hydration methods against the guideline-recommended hydration protocol for the prevention of PC-AKI in high-risk patients with severe CKD (eGFR < 30 mL/min/1.73 m2). Thus, the main focus of this trial is to evaluate IV hydration vs. oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD, who are scheduled for an elective contrast-enhanced CT-scan (CECT) with IV contrast-administration. Our research hypotheses consist of the following: Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 0.9% NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT. NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI, dialysis, renal adverse events, hospitalization, progression in CKD-symptoms, and all-cause mortality.

This study aims to find out whether people with chronic kidney disease [CKD] should take low dose aspirin to reduce the risk of first heart attack or stroke (cardiovascular disease [CVD]). CKD is common and is associated with an increased risk of CVD. CVD is caused by small blood clots and aspirin thins the blood to reduce the risk of such clots developing but it also increases the risk of bleeding. Aspirin is recommended to prevent further CVD in people who have already had a first CVD event (so called secondary prevention). Here the investigators want to study the use of aspirin as primary prevention in people with CKD who have not had a CVD to prevent the first event, to assess whether the potential benefits exceed the risks. Eligible patients will be recruited from their United Kingdom (UK) general practices and allocated by chance to be prescribed once daily low dose aspirin or usual care only. Follow-up will be for several years both electronically (for general practice, hospital and mortality data) and by annual questionnaires to ascertain CVD and bleeding events.

The investigators will conduct a pilot study to determine whether home-based exercise is an effective intervention to improve decreased physical function in kidney transplant candidates. The investigators will determine if home-based exercise improves frailty parameters and SPPB scores. The investigators will also determine if home-based exercise improves health-related quality of life (HRQOL), physical activity, and adverse clinical outcomes, including hospitalizations.